Shots:
Vertex announced topline results from its P‑II study of selective NaV1.8 inhibitor VX‑993 in 367 pts with acute pain post-bunionectomy; VX‑993 did not achieve a statistically significant improvement in SPID48 vs placebo
VX‑993 was safe and well tolerated at all doses, with AEs mostly mild/moderate; no SAEs related to VX‑993 and no discontinuations due…
Shots:
UroGen Pharma has reported P-III (ENVISION) trial data of Zusduri (mitomycin; QW, intravesical) as a chemoablative therapy for adults (n=240) with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
Trial showed a 24mos. DoR of 72.2% (Kaplan-Meier) in pts with CR at 3mos., with a mFU of 23.7mos. after 3mos. CR; the mDoR was…
Shots:
Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure
The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…
Shots:
The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC)
Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC
Additionally, Anbogen is pursuing global licensing,…
Shots:
Roche has reported data from the ongoing OLE P-III (Portal) study of Susvimo (port delivery platform with Lucentis) for the treatment of nAMD
The P-III (Archway) trial assessed Susvimo (Q6W refill, n=248) vs Lucentis (QM, IVT, n=168) in 415 nAMD pts responsive to prior anti-VEGF therapy; 352 entered the Portal OLE study, where 132…
This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Animal Health and Biosimilars. Check out our full report below:
Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients
Read More: Memo therapeutics
Eli Lilly Reports Topline P-III (BRUIN…
Shots:
Vir Biotechnology has enrolled the first pts in P-III (ECLIPSE 2) trial assessing tobevibart + elebsiran in CHD pts who have not achieved undetectable HDV RNA despite prior bulevirtide treatment
Trial will assess CHD pts treated with bulevirtide for ≥24wks., randomized to either switch to tobevibart + elebsiran or continue bulevirtide, with the 1EP…
Shots:
Ultragenyx has completed enrolment in its P-III (Aspire) trial to assess GTX-102 (apazunersen) in Angelman syndrome pts with confirmation of full maternal UBE3A gene deletion; Aurora study in more ages & genotypes to begin in H2'25
Trial will evaluate GTX-102 (intrathecal, 8mg QM for 3mos., then up to 14mg Q4M) vs a sham treatment…
Shots:
IMUNON has dosed the first pts with IMNN-001 in P-III (OVATION 3) trial for the treatment of women with newly diagnosed advanced ovarian cancer
Trial will evaluate IMNN-001 (100 mg/m², intraperitoneally, QW) + neoadj. & adj. CT vs CT alone in newly diagnosed stage 3C/4 ovarian cancer, incl. HRD+ pts who will receive PARP…
Shots:
AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in adults & adolescents with a mean baseline SALT score of 83.8
Trial incl. 2 replicate studies (Study 1 & 2) in AA pts (n=1399; 12-64yrs.), where both studies' Period A, pts were randomized to Rinvoq 15mg, 30mg, or…

